Cleared Special

K032297 - DISPOSABLE N-PE MICKROKERATOME BLADES
(FDA 510(k) Clearance)

K032297 · Oasis Medical, Inc. · Ophthalmic

Aug 2003

Decision

32d

Days

Class 1

Risk

K032297 is an FDA 510(k) clearance for the DISPOSABLE N-PE MICKROKERATOME BLADES, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on August 26, 2003, 32 days after receiving the submission on July 25, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K032297 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2003
Decision Date	August 26, 2003
Days to Decision	32 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF